None listed
Conditions
Interventions
Oxibendazole 200 mg Type of group
Patients receive single dose of 200 mg of Oxibendazole PO. Stool Samples will be obtained and examined on days 7, 14, 21 after treatment.
Group name:Oxibendazole 800 mg Type of group
Patients receive single dose of 800 mg of Oxibendazole PO. Stool Samples will be obtained and examined on days 7,14,21 after treatment.
Sponsors
SMITHKLINE BEECHAM INTERAMERICAN,
Eligibility
Inclusion criteria
Inclusion criteria: 1. External Patient, male or female between 18 and 65 years old a. Spoken or written consent must be obtained. b. To have infection by trichuris trichiura, shown in the stool samples obtained during the week before. Presence of any other type of helminths will not be cause for exclusion. 2. To be willing to fulfill the mentioned requirements and particularly to provide 3 stool samples on days 7, 14, 21 after treatment. 3. Female patients with potential to become pregnant, who have used an established method of birth control (surgical sterilization, intra-uterine contraceptive device, oral contraceptives, diaphragm in combination with contraceptive creams or foam, or condom in combination with contraceptive creams or foam) .
Exclusion criteria
Exclusion criteria: 1. The patient who has previously demonstrated a hypersensitivity reaction to benzimidazole or other related compounds. 2. Submitted patients who are not infected with Trichuris trichiura. Other species may also be present and the details of the response will be recorded. 3. The patient with diarrheal disease that could interfere with the evaluation of the stool sample and / or the patient has signs of dehydration. 4. The patient has received an anthelmintic in the 2 weeks prior to enrollment or study. 5. The patient has received an investigational drug within thirty days or five half-lives (whichever is the extension) of the screening visit or is scheduled to receive such a drug during the study period. 6. The patient has a concomitant infection or some other underlying disease which could compromise the diagnosis and evaluation of the response to study medication. 7. The patient has a known history of renal dysfunction (plasma creatinine> or = 1.5 times at the upper limit normal for age), or hepatic dysfunction (liver enzymes> or = 1.5 times at the upper limit of the range for age). 8. A woman who is pregnant, lactating or planning a pregnancy during the study or is not practicing any form of contraception. 9. The patient who is reluctant or unable to take part in this study. 10. The patient who has previously been enrolled in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Cure of infection by Trichuris trichiura (parasitological cure) shown by the absence of helminthian eggs in stool tests performed on day 15 of the study using the Kato Katz test. Measure:Cure of the Infection by Trichuris Trichiura Timepoints:15 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Cure of infection by Trichuris trichiura (parasitological cure) shown by the absence of helminthian eggs in stool tests performed on days 8 and 22 of the study using the Kato Katz test. Measure:Cure of infection by Trichuris trichiura Timepoints:Days 8 and 22 ; Outcome name:Cure of other associated helminth infections (parasitological cure) as demonstrated by the absence of helminth eggs in the stool tests performed on days 8, 15 and 22 of the study using the Kato Katz test. Measure:Cure of other associated helminth infections Timepoints:Days 8, 15, 22 ; Outcome name:Comparative reduction of helminth eggs to the basal numbers of Trichuris trichiura and others, in the patients who were not cured, showed in the stool tests performed on days 8, 15 and 22 of the study using the Kato Katz test. Measure:Comparative reduction of helminth eggs to the basal numbers of Trichuris trichiura and others Timepoints:Days 8, 15 and 22 ; Outcome name:Presence or absence of helminth eggs and larvae compared to the basal numbers of Trichuris trichiura and others in the stool tests performed on days 8, 15, 22 of the study using Spontaneous Sedimentation in a tube technique. Measure:Presence or absence of helminth eggs and larvae compared to the basal numbers of Trichuris trichiura and others Timepoints:Days 8, 15 and 22 | — |
Countries
Peru
Outcome results
None listed